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To investigate, through ethnography, changes in symptom burden and disability and their effects/interference on patient functioning, ability to perform activities of daily living (ADL) and quality of life (QoL) throughout the duration of one BoNT-A treatment cycle.
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| Measure | Description | Time Frame |
|---|---|---|
| Degree of functional limitations in daily life activities | Degree of functional limitations in daily life activities (i.e. physical functioning) associated with post-stroke spasticity as assessed by using WHODAS parameters, and identification of their characteristics and changes over time | monthly for 12 Weeks, or until end of injection cycle whichever occurs first |
| Health status in subjects with post-stroke spasticity | Health status in subjects with post-stroke spasticity as assessed by using EQ-5D-5L parameters, and identification of their characteristics and changes over time | weekly for 12 Weeks, or until end of injection cycle whichever occurs first |
| Severity of Pain | Severity of Pain as per EQ-5D-5L and a sliding scale. This is a descriptive scale that covers 5 dimensions: mobility, self-care, usual activities,pain/discomfort and anxiety/depression. the scale consist of 5 levels, where level one corresponds to "no problems" and level 5 corresponds to "extreme problem". | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Burden of spasticity/treatment | Themes/domains related to the everyday life experiences of subjects with post-stroke spasticity (e.g. burden disease/treatment) through qualitative analysis of in-depth open-ended interviews | Opening interview and ending qualitative interviews, ethnography data which will be provided at discretion of patient/caregiver for 12 weeks or duration of treatment, whichever occurs first, may also support these qualitative analyses |
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Exclusion Criteria:
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40 Adults subjects (male or female) suffering from post-stroke spasticity (the US, UK, France, and Italy), who are treated with BoNT-A in the course of routine clinical practice for focal spasticity
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| Name | Affiliation | Role |
|---|---|---|
| Ipsen Medical Director | Ipsen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ipsen Central Contact | Paris | France |
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| Patients' satisfaction | Subjects Report of Satisfaction with Treatment and their perception/desire of more tailored treatment options | weekly for 12 weeks or until end of injection cycle whichever occurs first. Opening and closing interview will also explore this |
| Comparison of feedback between caregivers and stroke survivors | Agreement between the themes elicited from semi-structured interviews between caregivers and subjects | opening ( before week 1) and ending ( 2 weeks after end of injection cycle) qualitative interviews |